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临床试验/NCT03167827
NCT03167827已完成4 期

Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor Musculature in Women in the Postmenopausal Period: Controlled Randomized Clinical Trial

Federal University of Uberlandia0 个研究点目标入组 22 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
22
主要终点
The change vaginal squeeze pressure

研究概览

简要总结

This study evaluates the effect of Physical Training and Supplementation of Isoflavone About Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the intervetion.

详细描述

The practice of physical exercise and isoflavone supplementation are ways of treating symptoms of climacteric, there is a lack of evidence as to whether these therapeutics when associated are useful for improving the strength, function, contraction pressure, electrical activity of the pelvic floor musculature of women in the Postmenopausal period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

Double Blind (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy postmenopausal woman
  • to be able to practice exercises on treadmill and weight exercises
  • without physical complications that prevent the execution of physical exercises
  • have no history of cardiovascular disease, diabetes, renal pathologies or hypertension
  • Present ability to contract the pelvic floor muscles

排除标准

  • Use hormone therapy or isoflavone
  • Use drugs that interfere with lipid and antihypertensive metabolism
  • Presence of cognitive impairment or neurological condition that could affect muscle activation
  • Present urinary tract infection at the time of data collection
  • Training pelvic floor muscle

结局指标

主要结局

The change vaginal squeeze pressure

时间窗: before and after the intervetion ( 10 weeks)

The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them. Outcome Measure of the vaginal squeeze pressure is cmH20 or Pascal.

The change Muscle function

时间窗: before and after the intervetion (10 weeks)

"PFM" evaluation was performed by vaginal palpation .During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the "PFM". Muscle function was classified by the Oxford Scale Modified that five grades of the force.

The change electromyography pelvic floor

时间窗: before and after the intervetion (10 weeks)

"PFM" electromyographic activity was collected during the resting to normalize the EMG data. No instruction regarding "PFM" contraction was given during the resting of the eight seconds. After, the volunteers were instructed to perform a maximal voluntary "PFM" contraction with the instruction to move "inward and upward" with the greatest possible force and to hold the contraction for five seconds. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them.

次要结局

未报告次要终点

研究者

发起方
Federal University of Uberlandia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasha Morena Bazílio Silva

physiotherapist

Federal University of Uberlandia

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